- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03486197
Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma
Phase II Trial of Neutron Radiotherapy With Concurrent Checkpoint Inhibitor Immunotherapy (Pembrolizumab) in Patients With Advanced Urothelial Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OUTLINE:
Participants receive pembrolizumab intravenously (IV) on days 1 and 22. On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42. Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 3 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Clinical Research Coordinator
- Phone Number: 206-897-2121
- Email: radoncrn@uw.edu
Study Locations
-
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutch/University of Washington Cancer Consortium
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pathologically proven (either histologic or cytologic) diagnosis of urothelial carcinoma
- At least two sites of disease that are measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Eligible for checkpoint inhibitor immunotherapy (pembrolizumab) per standard of care
- No history of autoimmune disease requiring systemic therapy (e.g. steroids or biologic agents)
- Absolute neutrophil count (ANC) ≥ 1500 /mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin > 9 g/dL
- Creatinine ≤ 1.5 x upper limit of normal (ULN) OR ≥ 60 mL/min
- Total bilirubin ≤ 1.5 ULN OR direct bilirubin ≤ ULN if total bilirubin > 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN OR < 5 x ULN if patient has liver metastasis
- Albumin >= 2.5 g/dL
- International normalized ratio (INR) or PT ≤ 1.5 x ULN unless on anticoagulation therapy, in which case prothrombin time (PT) or partial thromboplastin time (PTT) should be in the therapeutic range
- PTT ≤ 1.5 x ULN unless on anticoagulation therapy, in which case PT or PTT should be in the therapeutic range
- Eligible for neutron radiation treatment to 1-3 sites of metastatic disease (lesions do not have to be symptomatic)
- No steroids for at least 2 weeks prior to enrollment, and patient must not be expected to require steroids during the study period
- Zubrod performance status 0-2
- Patient must sign study specific informed consent prior to study entry
- Patients who are sexually active must use medically acceptable forms of contraception
- Life expectancy must be > 3 months
Exclusion Criteria:
- Has a known history of active TB (Bacillus tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients
- Has a known additional malignancy that is progressing or requires active treatment
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
- Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Has known history of, or any evidence of active, non-infectious pneumonitis
- Has an active infection requiring systemic therapy
- Has received a live vaccine within 30 days of planned start of study therapy
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided there is no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (Pembrolizumab, neutron radiation therapy)
Participants receive pembrolizumab IV on days 1 and 22.
On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42.
Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given IV
Other Names:
Undergo neutron radiation therapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate per immune-modified response evaluation criteria in solid tumors
Time Frame: Up to 3 years
|
Overall response rate will be calculated as the percentage of patients achieving a partial response or complete response, and will be presented along with the 95% confidence interval (CI).
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: Up to 3 years
|
This will be estimated with the Kaplan and Meier method with 95% CI obtained using Greenwood estimates of variance.
|
Up to 3 years
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Progression-free survival
Time Frame: Up to 3 years
|
This will be estimated with the Kaplan and Meier method with 95% CI obtained using Greenwood estimates of variance.
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jing Zeng, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9940 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- NCI-2018-00412 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- RG3118000 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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